Prytime’s pREBOA-Pro Catheter Receives Clearance for Extended Duration

October 8, 2025—Prytime Medical Devices, Inc. announced a new FDA 510(k) clearance for the pREBOA-Pro catheter, the company’s flagship device for partial resuscitative endovascular balloon occlusion of the aorta (pREBOA) procedures.

According to the company, the new clearance includes an expanded use profile that provides safe occlusion times up to 2 hours in Zone 1. Additionally, the new clearance contains a formal definition for partial occlusion.

Prytime stated that the pREBOA-Pro catheter is designed with flow channels that enable precise, smooth manual control of patient blood flow. The company stated that the device’s ability to precisely control arterial flow enables immediate stabilization of blood pressure and reduces blood loss while simultaneously diminishing the risk of distal ischemia and detrimental reperfusion sequelae associated with traditional REBOA.

The company noted that REBOA has traditionally been used reactively and often as a last resort, because of extremely limited 30-minute safe occlusion times; this clearance highlights the evolving capabilities available with its purpose-built partial balloon occlusion technology.

Chance Spalding, DO, a trauma and critical care surgeon at Mount Carmel East Hospital in Columbus, Ohio, serves as Prytime’s Chief Medical Officer.

“This new capability was designed with the surgeon in mind and helps eliminate a major barrier to broader utility,” commented Dr. Spalding in Prytime’s press release. “With this new pREBOA-Pro catheter, our surgical teams can safely intervene earlier and gain a new level of control, especially during the initial chaos seen in challenging trauma cases. Gaining control early reduces the collective temperature in the room and provides critical extended time to get to definitive intervention.”